Hämeenlinna Metabolic Syndrome Research Program: Oxidized LDL and Arterial Elasticity in Metabolic Syndrome and Controls (HMS-01) (HMS-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01114763
Recruitment Status : Completed
First Posted : May 3, 2010
Last Update Posted : May 4, 2010
Linnan Klinikka Oy
Information provided by:
Central Hospital of Kanta-Hame

Brief Summary:

Mechanisms that link metabolic syndrome to atherosclerosis are incompletely understood. As a part of Hämeenlinna Metabolic Syndrome Research Program (HMS), 40 men with metabolic syndrome and their 40 physically active controls (age: 30 to 65 years) are compared in a cross-sectional study. Except routine laboratory parameters, arterial elasticity and levels of oxidized LDL are determined.

Study hypothesis: Levels of oxidized LDL and findings in arterial elasticity may differ between subjects with metabolic syndrome and controls explaining the elevated risk for cardiovascular diseases among patients with metabolic syndrome.

Condition or disease
Metabolic Syndrome

Detailed Description:

Accumulation of oxidized low-density lipoproteins in the intimae of arteries together with risk factors known to enhance atherosclerosis, damage the endothelium of the arterial wall. Dysfunction of the endothelium leads into loss of elasticity of the artery. Especially a reduction in the elasticity of small arteries has been found prominent in atherosclerosis and is believed to serve as a marker for early stages of atherosclerosis.

In this study, we investigate whether the levels of oxidized LDL and arterial elasticity differ between patients with metabolic syndrome and their physically active controls. Oxidized LDL is assessed by a two-site ELISA immunoassay (Mercodia, Uppsala, Sweden). The capacitive elasticity of large arteries (C1) and the reflective elasticity of small arteries (C2) are automatically assessed by the CR-2000 as a mean of five most similar pulse waves appearing during the measurement. C1 identifies the elastic properties of aorta and other large arteries, C2 the endothelial function of the microvascular circulation. Proper statistical methods are used to reveal possible differences and their significance between the patients and controls.

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Hämeenlinna Metabolic Syndrome Research Program (HMS): Comparison of Men With Metabolic Syndrome and Their Physically Active Controls - Circulating Oxidized LDL and Arterial Elasticity
Study Start Date : June 2003
Actual Primary Completion Date : November 2005
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Metabolic syndrome
40 men with metabolic syndrome
40 physically active men

Biospecimen Retention:   Samples Without DNA
serum, EDTA plasma, citrate plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic.

Inclusion Criteria:

Group 1: Metabolic syndrome

  • 40 Finnish men with metabolic syndrome (MetS) defined according to National Cholesterol Education Program (NCEP) Adult Treatment Panel III
  • MetS diagnosed in routine health examination and laboratory tests
  • Age: 30 to 65 years

Group 2: Control

  • 40 age-matched men
  • Exercise physically more than three times a week and more than 30 minutes per exercise on regular basis
  • Never been studied or treated because of cardiovascular disease

Exclusion Criteria:

  • Cholesterol-lowering medication
  • ACE-inhibitor medication
  • Angiotensin-receptor blocker medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01114763

Linnan Klinikka
Hämeenlinna, Finland, 13100
Central Hospital of Kanta-Häme
Hämeenlinna, Finland, 13530
Sponsors and Collaborators
Central Hospital of Kanta-Hame
Linnan Klinikka Oy
Study Director: Ari K Palomäki, MD PhD Central Hospital of Kanta-Häme
Study Director: Kalevi Oksanen, MD PhD Central Hospital of Kanta-Häme

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ari Palomäki, MD PhD, Head of department, Central Hospital of Kanta-Häme, Hämeenlinna, Finland Identifier: NCT01114763     History of Changes
Other Study ID Numbers: KHMetS-01-AP
First Posted: May 3, 2010    Key Record Dates
Last Update Posted: May 4, 2010
Last Verified: April 2010

Keywords provided by Central Hospital of Kanta-Hame:
Metabolic Syndrome
Oxidized Low Density Lipoprotein
Arterial Elasticity
Diabetes Mellitus
Cardiovascular Diseases

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases